Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Substance Use Disorder

September 6, 2022 updated by: Joanna G Katzman, University of New Mexico
The purpose of this pilot-study is to to distribute naloxone auto-injector in a "Universal Precaution" manner to patients with opioid substance use disorder. The objectives are to decrease the number of fatal and nonfatal overdose deaths, to examine and understand the risk factors for serious opioid toxicity and overdose, and to evaluate the unintentional opioid overdose risk utilizing an evidence-based screening questionnaire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

402

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • UNM Hospitals - Alcohol and Substance Abuse Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients treated with methadone, naltrexone or buprenorphine as medication assisted treatment at the UNM Addiction and Substance Abuse Program (UNM ASAP) aged 18 or older

Exclusion Criteria:

  • Subjects who are allergic to naloxone and its inactive ingredients. Inactive ingredients include buffering agents.
  • Subjects younger than 18.
  • Subjects not being treated at UNM ASAP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with opioid substance abuse disorders
All participants will receive Naloxone autoinjector as a preventative tool for accidental opioid overdose
Behavioral: Naloxone Auto-Injector
Naloxone auto-injector is the only product FDA approved and labeled for use by family members or caregivers for emergency therapy and rescue wherever opioids are present. Bystanders of patient are able to provide naloxone when drug overdose occurs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of fatal over dose deaths by use of naloxone auto-injector co-prescribing from the University of New Mexico Addiction and Substance Abuse Program (UNM ASAP)
Time Frame: 2 years
Patients on chronic opioid therapy will be co-prescribed a naloxone-autoinjector rescue kit to decrease the accidental overdose rate associated with these medications.
2 years
number of near fatal overdoses prevented by use of naloxone auto-injector co-prescribing from the University of New Mexico Addiction and Substance Abuse Program (UNM ASAP)
Time Frame: 2 years
Patients on chronic opioid therapy will be co-prescribed a naloxone-autoinjector rescue kit to decrease the accidental overdose rate associated with these medications.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

Kaleo Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2016

Primary Completion (Actual)

May 16, 2017

Study Completion (Actual)

August 20, 2020

Study Registration Dates

First Submitted

December 21, 2015

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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